FDA ACCEPTS ACUPUNCTURE NEEDLES AS APPROVED MEDICAL DEVICE
A TRIUMPH OVER 20 YEARS OF PROFESSIONAL DISCRIMINATION

 Professor DaRen Chen, L.Ac., O.M.D., Q.M.E.
Chief Adviser, American Institute of Chinese Medicine

April 3^rd, 1996

In the beginning of 1991, Dr. Dean Edell, the medical anchorman of the American Broadcasting Company (ABC), thrice attacked Chinese medicine violently on Channel 7, KGO, San Francisco. He stigmatized the 5,000-year-old Chinese acupuncture as ‘based on primitive concepts’, ‘has no scientific basis’, ‘acupuncture is not effective for any sickness at all’, etc. He even advocated that acupuncture licensure be terminated and insurance companies not pay for acupuncture treatment. He negated Chinese medicine completely. Actually, he wished to wipe out Chinese medicine from the United States of America.

In the USA, Chinese medicine is an exotic phenomenon. Many doctors of Chinese medicine are minorities here. It is therefore understandable that discrimination of Chinese medicine has long existed. However, it is definitely not a fortuity that the professionals of Chinese medicine should confront such malicious and violent attacks even though, at that time, practice of acupuncture had already been legalized for 16 years.  In fact, the American general public have welcomed Chinese medicine and gladly accepted it, thus threatening the authorities of orthodox western medicine. They then tried to launch an attack in an attempt to stop this historical progress. The Dean Edell incident signified that the progress of Chinese medicine has reached a new era in America. We, the practitioners of Chinese medicine, must do everything in our power to raise our academic status within the American society; otherwise, the discrimination against us will never be able to be radically reversed.

In the early 70’s, acupuncture began to disseminate into America openly because of President Nixon’s historic visit to China. Since then a wave of ‘acupuncture heat’ was generated in the Western Hemisphere, and at the same time, a new epoch was ushered into America for the development of Chinese medicine. According to statistics, as many as 6,000 acupuncturists are practicing in all parts of America. In addition, there are about 3,000 doctors of Western medicine also using acupuncture to treat their patients. About 10 million people receive acupuncture treatment every year.  Many newspapers, magazines, radio stations and television shows are regularly and vividly reporting many stories of the miraculous effects of acupuncture and Chinese medicine. Thus it can be seen how this Chinese healing art is becoming well loved and accepted by American people.  In reality, they love it and support it because it is indeed effective in clinical practice. For this reason, politicians here have also shown considerable appreciation and support toward the campaign of acupuncture in last two decades. The political status for the professionals of Chinese medicine has been relatively stable. However, by comparison, the academic strength of the American Chinese medicine field is rather weak so far (Note 1). The educational system of Chinese medicine is still immature (Note 2). The research work is quite slow; in particular the fundamental studies, which are acceptable to the Western scientific community, are even rare (Note 3). All these factors would easily invite attack and constitute a fatal weakness for the fledgling Chinese medicine in America.

Many people of insight in our profession realize that facing this new era, encouragement of academic studies and promotion of academic exchange are of crucial importance to the profession. Since 1990, the Chinese medicine community has started to tackle this problem seriously and have achieved encouraging results. In recent years, the academic activities of acupuncture have been centered upon collecting and sorting out the latest scientific research data on the efficacy of acupuncture done by eminent scientists in America and all around the world in an attempt to win over a deserved status of acupuncture within the American medical system.

Dating back to 1975, acupuncture was legalized by many states in America; however, political legalization is not equivalent to academic recognition. The American Medical Association (AMA), the major representative of the Western medical community, has still not recognized the medical value of acupuncture. Its official stand has always been ‘Acupuncture in USA has still been experimental’. Because of it, the Food and Drug Administration (FDA) has not seen acupuncture needles as a formal medical device but has dismissed it as an ‘investigational device’, allowed only for the use of experimental purposes. Owing to the fact that the FDA is awed by the general public’s support of acupuncture, this regulation has never been conscientiously implemented for 2 decades, but it alone has seriously restricted the development of Chinese medicine. For example, because acupuncture is still in an “experimental stage”, MEDICARE, a federal health plan system, has still not recognized acupuncture resulting in hundreds of thousands of elderly and disabled people being denied the benefit of acupuncture treatment.

Promoted by leaders of American acupuncturists, on April 21-22, 1994, an ad hoc meeting sponsored by the National Institute of Health (NIH) was held at Gaithersburg, Maryland, to examine the status of acupuncture needles. Acupuncturists presented to the FDA officials a series of detailed research reports regarding the curative effects of acupuncture in the treatment of five conditions: chronic pain, vomiting, alcoholic and drug addiction, asthma and sequelae of stroke. These high-quality research studies were conducted utilizing very strict modern scientific procedures and controls. To name just a few: A study regarding the safety of acupuncture was done by Dr. Lixing Lao, an expert in Chinese medicine at Maryland University; Research on the relation between acupuncture and endorphins was carried out by Dr. Bruce Pomeranz, a professor of physiology at the University of Toronto, Canada; The acupuncture treatment for drug addiction was performed by Dr. Michael Smith, director of Substance Abuse Division, Lincoln Hospital, New York. The FDA have obtained a series of valuable scientific data from these reports, convincing and emphatically arguing that acupuncture is perfectly safe and effective in the treatment of the aforementioned five ailments according to western conventional standards.

Then in November, 1994, the acupuncture professional retained the Law Office of Swankin and Turner in Washington D.C. to present a ‘Citizen’s Petition’ to the FDA, solemnly requesting the agency to reconsider the healthcare status of acupuncture needles according to the research reports provided by those specialists of acupuncture -- to re-classify acupuncture needles from an ‘Investigational Device’ to an ‘Approved Medical Device’. This petition was indeed an unprecedented challenge to the FDA, which admitted that since starting to control medical devices in 1973, acupuncture needles are the simplest device they have ever examined, and also the first non-Western medical device that they have ever approved. In fact, it took more than a year for the FDA to analyze and assess the reports from the research experts. Eventually, they made a decision appropriate to the historical current. Although the new policy still contains many restrictions, undoubtedly, it can be regarded as landmark progress.

From the news spread by the media, we can see that the American public has greatly appreciated and welcomed the FDA’s resolution. To the Chinese medicine community, this new ruling has generated tremendous encouragement, because they realize that it will greatly fortify the development of acupuncture. Owing to the fact that the FDA has officially given the green light to acupuncture needles, not only could the Federal Medicare program start to include acupuncture services to their coverage, but all departments of the Federal Government, the largest employer in America, could also provide their employees (including officers of every ranking) with the benefit of acupuncture treatment. All the senators and representatives in the Congress with their subordinates, even millions of personnel of military services and their families would have the chance to enjoy the benefits of acupuncture.  Most important of all, large private insurance companies would change their policies and offer acupuncture in their coverage.

We would like to point out that considering the long-term development of the profession of Chinese medicine, the significance of the FDA’s new policy toward acupuncture needles is not merely on the side of economics. This new policy signifies that the American medical authorities have officially recognized the scientific nature of acupuncture treatment, whereby the academic status of Chinese medicine will be radically changed in America. Through 20 years of arduous struggle, the professionals of Chinese medicine have eventually triumphed over the academic discrimination for the first time. Its influence is profound and far-reaching. Hereafter, the anti-Chinese medicine forces can no longer use ‘not scientific’, ‘primitive concepts’ or similar slanders to suppress Chinese medicine.

According to a poll conducted by San Francisco Chronicle, people who receive acupuncture treatment amount to only 1% of the population. Even in California where Chinese medicine is most popular, only 2% of the census population has had acupuncture treatment. This statistic reflects that there are many man-made discriminative restrictions toward acupuncture. It is hopeful that this irrational situation will be progressively reversed by the FDA ruling. At the present moment, there are still 19 States where practicing Chinese medicine is illegal and 4 other states in which acupuncturists cannot practice independently. The FDA’s new ruling will also provide these States with an important legal basis to revise their legislation.  It is predictable that Chinese medicine will be legalized in the whole nation of America in the very near future. To achieve all this, incorporating Chinese medicine into the American main healthcare system becomes a basic premise. We are marching on steadily in this direction.

Note 1: It is worthy to point out that, although acupuncture originated in China, and about half of the 6,000 acupuncturists in America are Chinese, we, the Chinese acupuncturists, in this important academic battle, have not generated the power like a main force. There were only 3 Chinese scientists among the 35 experts attended the ad hoc meeting of the NIH: They were Dr. Xiao Ming Tian, consultant to the World Health Organization, (originally of the Beijing Medical University); Dr. Lixing Lao, professor of the Maryland University, (originally of the Shanghai College of Traditional Chinese Medicine); and Dr. Jing Nuan Wu, president of the Tao Health Prevention Institute, Washington.

Note 2: The formal education of Chinese medicine in America began in 1975. It was a 2-year course equivalent to technician’s level without offering any academic degree. Presently, there is about 47 colleges of Chinese medicine in USA, offering courses of Master degree, requiring credits of 2-year preparatory courses for admission. Except in the state of Nevada and the Workmens’ Compensation System in California, acupuncturist does not have the status of a physician.

Note 3: According to the report of Mr. Rick Weiss of Washington Post, about 2,500 papers on acupuncture written in English published since 1960 have been collected and gone through very strict mathematical and statistical analyses (especially assessment of the design of the experiment and the handling of the numerical data). The scientists have accepted only 28 papers. This means that only 1.2% of the studies conformed to the rigorous qualitative and quantitative standards of the modern sciences.

Note 4: If one follows FDA’s routine procedures, FDA should have its ruling for the petition on acupuncture needle status in six to eight months (due last June).  However, under the pressure from some anti-Chinese medicine powers, such as AMA’s own petition to FDA on the same issue, warning FDA, a non-medical office, should not judge any medical practice, ruling for this simple petition was extremely delayed.

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